EP3142586B1 - Catheter device for transmitting and reflecting light - Google Patents

Catheter device for transmitting and reflecting light Download PDF

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Publication number
EP3142586B1
EP3142586B1 EP15792211.3A EP15792211A EP3142586B1 EP 3142586 B1 EP3142586 B1 EP 3142586B1 EP 15792211 A EP15792211 A EP 15792211A EP 3142586 B1 EP3142586 B1 EP 3142586B1
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EP
European Patent Office
Prior art keywords
patch
balloon
light
shaft
catheter device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP15792211.3A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3142586A1 (en
EP3142586A4 (en
Inventor
Conor Walsh
Ellen Roche
Panagiotis POLYGERINOS
Lucia SCHUSTER
Jeffrey Karp
Yuhan Lee
Pedro Del Nido
Fabozzo ASSUNTA
Ingeborg FRIEHS
Steven Wasserman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Harvard College
Brigham and Womens Hospital Inc
Childrens Medical Center Corp
Massachusetts Institute of Technology
Original Assignee
Harvard College
Brigham and Womens Hospital Inc
Childrens Medical Center Corp
Massachusetts Institute of Technology
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Publication date
Application filed by Harvard College, Brigham and Womens Hospital Inc, Childrens Medical Center Corp, Massachusetts Institute of Technology filed Critical Harvard College
Priority to PL15792211T priority Critical patent/PL3142586T3/pl
Priority to EP20199089.2A priority patent/EP3821818A3/en
Publication of EP3142586A1 publication Critical patent/EP3142586A1/en
Publication of EP3142586A4 publication Critical patent/EP3142586A4/en
Application granted granted Critical
Publication of EP3142586B1 publication Critical patent/EP3142586B1/en
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    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
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Definitions

  • a ventricular septal defect is an abnormal communication between the right and the left ventricle of the heart in the form of a hole in the septum, which can lead to ventricular disfunction and pulmonary hypertension. Illustrations comparing a normal heart septum with a heart that suffers from a ventricular septal defect are provided in FIGS. 1 and 2 .
  • the ventricular septal defect is the most common congenital cardiac defect and cause of death in infants under one year.
  • the invention provides an insertable light-dispensing catheter device, comprising:
  • Apparatus and methods for transmitting light through a catheter device particularly to cure an adhesive that secures a patch delivered through the catheter to repair a congenital, acquired, or iatrogenic tissue defect, such as a ventricular septal defect, are described herein, where various embodiments of the apparatus and methods may include some or all of the elements, features and steps described below.
  • Embodiments of the catheter device that transmit and change the direction of light while, optionally, simultaneously applying pressure to a biocompatible, photocurable adhesive from the opposite side of a defect in biological tissue, thereby closing or significantly reducing the size of the defect.
  • Embodiments of the catheter device represent an alternative to the currently available therapies for intra-cardiac septal defect closure (surgical and trans-catheter procedures), which are associated with early and late complications due to tissue damage from anchoring devices or sutures. These embodiments are based on a uniquely designed system for delivery of an ultraviolet (UV) light activated adhesive for attachment of a biodegradable patch on a balloon treated with UV-reflecting layer.
  • UV ultraviolet
  • the device was originally designed for the closure of ventricular septal defects, the technology can easily be applied to the closure of other defects, or indeed for other applications as is detailed below.
  • Embodiments of the device and methods can provide numerous advantages and benefits, including the following.
  • the device can achieve patch-to-tissue adhesion by transmitting, reflecting and spreading UV light, with no mechanical anchoring and without leaving any permanent foreign material in the body.
  • the device can be designed to allow minimally invasive access to the defect site, even in extremely challenging, hard-to-access anatomical settings. The entire procedure can be easily visualized and monitored with 2D and 3D ultrasound or endoscopic guidance. Additionally, the device can quickly and consistently deploy and release the patch to rapidly achieve occlusion of a body defect opening with adhesion to internal tissue. Finally, the presence of a stabilizing balloon can ensure adequate compression forces to achieve adhesive activation.
  • an elastic biodegradable adhesive can provide adequate tissue fixation, enduring cyclical and shear forces.
  • the device is also amenable to growing tissues (for example, for implanting in the pediatric population), where permanent devices can be problematic.
  • the device may remain in the body for less than five minutes without any long-term adverse device-related complications foreseen.
  • components of the device that are left in the heart can be completely compliant/elastomeric and/or biodegradable. These characteristics can minimize local tissue damage (e.g., by substantially matching the elasticity of the tissue) and the amount of foreign materials left in the heart (and resultant foreign body response) and can act as a scaffold for tissue repopulation and septum self-healing. Accordingly, the device can be particularly advantageous for use on delicate and friable tissue.
  • embodiments of the methods and apparatus described herein may omit any mechanical attachment of patch to septum (e.g., unlike most of the known prior art, there is no need for mechanical means of anchoring in the heart). Consequently, methods and apparatus described herein reduce risk of local tissue damage. Instead, an elastomeric patch and adhesive that are tailored to match the elasticity of the heart can be used.
  • a flexible, inflatable and non-stick substrate e.g ., a balloon
  • deployable applicator can be used to apply pressure to a patch and adhesive while curing.
  • the apparatus can have a smaller profile, making it more suitable for use on infants or young children (resulting in reduced problems/complications in infants and children), which is important, as a ventricular septal defect is preferably treated before the patient reaches one year of age.
  • use of the device is substantially less invasive and does not require open heart surgery or cardiopulmonary bypass to provide the patch. Rather, the apparatus and methods can be used to provide a patch in vivo on the septum of a beating heart.
  • a retrieval catheter shaft can extend from the stabilization/support balloon; and the balloon with the mirror can be removed through that catheter shaft after the patch is adhered to the internal tissue.
  • Percentages or concentrations expressed herein can represent either by weight or by volume. Processes, procedures and phenomena described below can occur at ambient pressure (e.g ., about 50-120 kPa for example, about 90-110 kPa) and temperature (e.g ., -20 to 50°C for example, about 10-35°C) unless otherwise specified.
  • first, second, third, etc. may be used herein to describe various elements, these elements are not to be limited by these terms. These terms are simply used to distinguish one element from another. Thus, a first element, discussed below, could be termed a second element without departing from the teachings of the exemplary embodiments.
  • the various components identified herein can be provided in an assembled and finished form; or some or all of the components can be packaged together and marketed as a kit with instructions (e.g ., in written, video or audio form) for assembly and/or modification by a customer to produce a finished product.
  • Embodiments of the device can include a distal balloon 21, a reflective coating (mirror) on the balloon 21, multiple shafts in the catheter, a light-activated adhesive 46, and a patch 22.
  • FIG. 3-7 illustrates a distal balloon 21, a reflective coating (mirror) on the balloon 21, multiple shafts in the catheter, a light-activated adhesive 46, and a patch 22.
  • FIG. 3-7 illustrates a distal balloon 21, a reflective coating (mirror) on the balloon 21, multiple shafts in the catheter, a light-activated adhesive 46, and a patch 22.
  • a balloon 21 with a plasma surface treatment and an aluminum-poly(p-xylylene) coating a poly-glycerol-sebacate urethane (PGSU) patch 22 with spread poly-glycerol-sebacate acrylate (PGSA) adhesive 46
  • PGSU poly-glycerol-sebacate urethane
  • PGSA poly-glycerol-sebacate acrylate
  • an inner shaft 23 that incorporates the optical fiber 29 and saline and deploys the distal balloon 21 and patch 22
  • an intermediate single or multi-lumen shaft 24 that deploys the proximal balloon 40 an 6.0 - 6.6 mm (18.0-20.0 F) introducer shaft 25
  • a handle 26 an inner-intermediate shaft coupling/decoupling mechanism in the form of a sliding mechanism 27, a Y-connector 28, an optical fiber optic 29 inserted through the Y-connector 28, a light source 30 (that produces, e.g., UV light), an inflation device 31, and
  • the distal balloon 21 can be a medical balloon coated with a metallic and protective/omniphobic coating and can include two layers 36 and 38.
  • the distal balloon 21 can accomplish the following three functions: (a) deploying the patch 22 through temporary sutures 34 attaching the patch 22 to an outer layer on the distal balloon 21 so that it deploys with the balloon 21 (b) applying a compressive force onto the patch 22 and stabilizing the patch 22 during the curing process, and (c) reflecting light to the septal surface exposing the adhesive 46 to light through the patch 22 for curing.
  • the balloon 21 can be formed of, e.g., urethane, which can withstand high pressure, provide good conformance on the surface geometry (thereby preventing damage to the internal tissue), and transmit more than 20N of force to the patch 22 (for glue curing).
  • the distal balloon 21 has a conical shape, though the balloon 21 can take on other shapes.
  • the balloon 21, itself can be made of a bioabsorbable material; and the catheter can inflate the balloon 21, provide light for curing, and then detaches from the balloon 21, leaving the balloon 21 behind for closure of the ventricular septal defect 20.
  • the coating can be in the form of a multi-layer coating including a plasma surface treatment and a vapor deposited aluminum, poly(p-xylylene) (e.g . ,Parylene-C) coating and/or an anti-thrombogenic coating.
  • a plasma surface treatment e.g . ,Parylene-C
  • poly(p-xylylene) e.g . ,Parylene-C
  • reflectance of greater than 90% has been achieved with the mirror coating.
  • poly(p-xylylene) can serve as a protective coating material for the reflective balloon 21.
  • the poly(p-xylylene) deposition process does not influence the reflective coating reflectivity significantly.
  • the mirror can be provided on/toward the distal tip of the light guide inserted into the distal balloon 21 ( e.g., in a light-emitting shaft 23 inserted into the balloon 21 beyond the distal tip of an optical fiber 29 positioned within the shaft 23 and through which the light is delivered) to reflect and distribute the light back onto the patch 22.
  • the balloon 21 with the mirror can be contained in an outer balloon layer 36.
  • a suture 34 can pass through the outer balloon layer 36 and through the patch 22 so that the patch 22 deploys with expansion of the balloon 21.
  • An end of the suture 34 can be pulled outside the body through the outer shaft 25 to release the secured patch 22 from the outer layer of the balloon 21.
  • the distal balloon can be replaced with a foldable/unfoldable sheet for delivering patch 22 and adhesive 46.
  • the adhesive 46 can be contained in the patch 22 and released when pressured by force from the inflated distal balloon 21.
  • the multiple shafts that form the catheter can include the following: (a) an outer shaft 25 for device insertion, securement to the right ventricle 16 and protection of inner components; (b) an intermediate shaft 24 that advances through the ventricular septal defect 20 with the distal balloon 21 and the patch 22 and that retracts to deploy the distal balloon 21 and patch 22 inside left ventricle 18; and (c) an inner shaft 23 that deploys the distal balloon 21 and protects the light guide on insertion. Relative movement of the shafts 23, 24, and 25 can be controlled by the handle 26, with locking mechanisms for the shafts 23, 24, and 25.
  • the catheter which can have an outer diameter of about 8 mm or less, can also include an injection lumen leading to the applicator tool on the septum 14.
  • the adhesive 46 can be in the form of a poly-glycerol-sebacate acrylate (PGSA) or alternative light-activated glue.
  • PGSA poly-glycerol-sebacate acrylate
  • a suitable form of PGSA is described in N. Lang, M. J. Pereira, Y. Lee, I. Friehs, N. V. Vasilyev, E. N. Feins, K. Ablasser, E. D. O'Cearbhaill, C. Xu, A. Fabozzo, R. Padera, S. Wasserman, F. Freudenthal, L. S. Ferreira, R. Langer, J. M. Karp, P. J. del Nido, A Blood-Resistant Surgical Glue for Minimally Invasive Repair of Vessels and Heart Defects.
  • the adhesive 46 is both biocompatible and biodegradable and is activated via exposure to light (e.g ., ultraviolet light).
  • the adhesive 46 can be coated on the patch 22 before the device is inserted into the patient.
  • the adhesive 46 can be stored in reservoirs in the patch 22, where the reservoirs are sealed with removable absorbable/pressure-sensitive adhesive 46 that is released when pressure is applied by the expanding balloon 21.
  • the reservoirs can be sealed with valves.
  • applying pressure may cause chambers to burst to release other type of adhesive (for example thermally curing adhesive or adhesive that cures on contact with water).
  • the adhesive 46 can be injected through the catheter in vivo.
  • a ring-shaped adhesive delivery dispenser 42 is shown in FIG. 31 , wherein adhesive 46 is delivered through conduits 43 extending along the intermediate shaft 24 to the adhesive dispenser 42, which releases the adhesive 46 to flow into contact with the patch 22.
  • Another embodiment of the adhesive dispenser 42 is shown in FIGS. 32 and 33 , which also show tabs 48 on the distal balloon 21 with sutures 34 for patch attachment.
  • Yet another embodiment of the adhesive dispenser 42 is shown in FIGS. 34 and 35 , where the shafts 23, 24, and 25 include a steering angle (bend) 44 toward a distal end of the shafts adhesive 46 can be seen flowing through the dispenser 42 in FIG. 35 .
  • the patch 22 can be designed to cover/bridge a defect 20 or to reinforce tissue; in additional embodiments, the patch 22 can be in the form of a flexible sensor (e.g., an electrical sensor for detecting electrical abnormalities on the surface of the heart) or a drug- or cell-delivery agent (where drugs or cells are coated on and/or contained by the patch 22) to monitor or treat the underlying tissue.
  • the patch 22 can be formed of optically transparent poly-glycerol-sebacate urethane (PGSU), hydrogel or alternative optically transparent and flexible patch/sensor/drug or cell delivery device. Providing the patch 22 with transparency and elasticity enable proper activation and adhesion of the adhesive 46 to bind the patch 22 to, e.g., cardiac tissue.
  • the patch's elasticity also enables leaving a minimal residual ventricular septal defect 20 after the distal balloon 21 is removed from the heart 12 passing through the patch 22 [ e.g., through intersecting ( e.g ., cross-shaped) slits in the patch 22].
  • two patches 22 can be employed, wherein one of the patches is applied on each side of the septum 14 or apical wall and pressed against the septum 14 or apical wall by respective balloons 21 and 40.
  • the patch 22 can be in the form of a plug.
  • the patch 22 can be in the form of a three-dimensional (3D) shaped patch with a self-sealing or valved feature in the patch 22 to seal after catheter retraction through the patch 22.
  • the light guide passing through the catheter to deliver light to the distal balloon 21 can be in the form of an optical fiber 29.
  • the optical fiber 29 can have a conical sculptured fiber tip (or a tip that is otherwise optimized for light distribution in combination with the shape of the balloon/mirror) at its distal end ( e.g., inside the balloon 21) that provides desirable light ray path to reflect the light onto the patch 22 on the septum 14 for curing.
  • the light guide is in the form of one or more bundles of optical fibers 29.
  • the distal tips of the optical fibers 29 are flat or have another geometry, and the mirror is shaped to provide the desired light distribution.
  • the residual hole in the patch 22 can be sealed via a catheter that can apply and cure additional adhesive 46 following retraction through the patch 22 or through the use of a second patch 22, applied with a catheter on the opposite side of the tissue.
  • the device presented here has numerous potential applications, and although the experiments here were conducted with PGSU and HLAA, any optically transparent patch material (e.g ., pericardium, dacron, polyurethane) can be used.
  • the device is scalable, and the size or geometry of the distal balloon 21 or patch 22 can be specified based on patient-specific needs ( e.g., from pre-procedural imaging).
  • the device is a multi-functional, catheter-based technology with no implantable rigid components that functions by (i) unfolding an adhesive-loaded elastic patch 22, (ii) deploying a double-balloon 21 and 40 to stabilize and apply pressure to the patch 22 against the tissue defect site and (iii) uniformly dispersing ultra-violet light via a fiber optic 29 and a reflective metallic coating for adhesion activation.
  • a perventricular surgical approach can be performed through a right thoracotomy; and the heart 12 can be exposed by opening of the pericardium.
  • the procedure can be monitored and the delivery device visualized with. e.g ., 2D- and 3D-echocardiography, 2D- and 3D magnetic resonance imaging, or with x-ray (fluoroscopy).
  • the device enters the heart 12 via a trans-ventricular approach, where the distal balloon 21 and patch 22 are inserted through the right ventricle 16, through the ventricular septal defect 20, and into the left ventricle 18.
  • the device enters the heart 12 through a transvascular or transatrial approach.
  • FIGS. 16-20 respectively show the following stages in a trans-ventricular approach: preparation, access, deployment, adhesion, and removal.
  • the device can then be introduced into the heart 12 from an incision in the right ventricular wall.
  • the outer shaft 25 can remain inside the right ventricle 16, while the intermediate shaft 24 can be advanced over the guidewire through the ventricular septal defect 20 into the left ventricle 18.
  • the inner shaft 23 can then be advanced, allowing the self-expansion of the patch 22, wherein the patch 22 is already covered with the adhesive 46 on the septal facing surface (folded into the intermediate shaft 24); and the distal balloon 21 is deployed.
  • the distal balloon 21 can then be inflated and a UV fiber optic 29 (or other form of light guide) can be advanced into it.
  • a UV fiber optic 29 or other form of light guide
  • the distal balloon 21 can press against the patch 22 and tissue surface, as shown in FIG. 18 .
  • a second stabilizing balloon 40 can be simultaneously inflated on an opposite side of the septum 14. While compressing the patch 22 with the distal balloon 21, the UV light transmitted through the optical fiber 29 can be reflected by the aluminum surface coating on the distal balloon 21 onto the glue 46 ( e.g., for up to 5 seconds) to cure the glue 46 while simultaneously applying pressure to the glue 46, as shown in FIG. 19 .
  • the suture 34 joining the patch 22 to the outer balloon layer 36 can be removed (by pulling one end of the suture 34 to release the patch 22 from the outer balloon 36); and the balloons 36 and 38 can then be retracted through the patch 22, leaving only a minimal residual defect 20, and the catheter can be withdrawn, as shown in FIG. 20 .
  • FIG. 46 An alternative design with a partially reflective mirror 56 in the inner shaft 23 is shown in FIG. 46 , where the light is emitted from the end of the fiber optic 29 in an optically transparent inner shaft 23 to a partially reflective, conical mirror 56 that deflects and diffracts the light across a range of angles; and the light then bounces off the reflective surface of the balloon 21 to the patch 22 and adhesive 46.
  • Stepwise schematics for an exemplification of a process for closing a ventricular septal defect 20 are provided in FIGS. 25-30 .
  • the device is inserted through the right atrial appendage and through the septal defect 20; next, the patch 22 is mechanically deployed to cover the septal defect 20.
  • the anchoring balloon 40 is then inflated via a conduit passing through the patch 22, as shown in FIG. 26 .
  • Adhesive 46 is then flowed between the patch 22 and the septal wall surface contacted by the patch 22, while the inflated anchoring balloon 21 presses the patch 22 against the septum 14, as shown in FIG. 27 .
  • the inner reflective coating of the distal balloon 21 prevents dispersion of light from the fiber 29 into the heart 12.
  • the distal balloon 21 is then deflated and removed through a valve design in the center of the patch 22 to leave just the adhered patch 22 on the far side of the septum 14, as shown in FIG. 29 .
  • the device is removed, leaving just the adhered patch 22 in the heart 12, as shown in FIG. 30 ; and the atrial access point is sutured with purse string.
  • the patch 22 is in the form of a PGSU plug with collapsible wings that collapse and expand with the distal balloon 21 and with a neck 50 that extends along the shaft 23 to shield the shaft 23 from overflowing adhesive 46.
  • the proximal balloon 40 is mounted inside the neck 50 of the plug 22 and pushes outward on the neck 50 to secure the device in the septum defect 20.
  • the proximal balloon 40 is also coupled with an inner pneumatic conduit for delivering a fluid to inflate the proximal balloon 40.
  • FIG. 37 shows inflation of the distal balloon 21 and the expansion of the plug wings 22, while FIG.
  • FIG. 38 shows insertion of the fiber optic 29 through the shaft 23 into the distal balloon 21.
  • FIG. 39 light is transmitted through the fiber optic 29 and dispersed (reflected and refracted) at various angles around the distal balloon 21 until the light reflects off of the reflective inward-facing surface of the distal balloon 21.
  • FIG. 40 Another embodiment is shown in FIG. 40 , wherein the distal balloon 21 includes a mirror 52 at the top of the balloon 21 (in the orientation shown). Light can be directed directly upward (in this orientation) from the optical fiber 29 across the balloon 21 into contact with the mirror 52, which disperses the light upon reflection.
  • FIG. 41 Use of an embodiment of the device for intracardiac defect closure is further illustrated in FIG. 41 , where the distal balloon 21 reflects light back on the patch 22 and adhesive 46, and where the patch 22 seals a hole in the septum 14 when the adhesive 46 cures.
  • an embodiment of the device is used for epicardial patch delivery, as shown in FIG. 42 .
  • the device need not pass through the wall to be patched. Rather, the distal balloon 21 and patch 22 remain on the same side of the wall as the shaft 25 so that the distal balloon 21, upon inflation, can press the patch 22 onto the outer surface of the epicardium.
  • the patch 22 can be applied for cell/drug delivery through the patch 22 to the epicardium or for ventricle reinforcement for heart-failure patients.
  • the light is focused forward inside the distal balloon 21 to the far side of the distal balloon 21 where the patch 22 is attached.
  • a suction tool incorporated into the device can provide a suction bond with the epicardium to stabilize the patch 22.
  • the device can also incorporate a central needle or multiple microneedles for cell/drug injection.
  • FIGS. 43 and 44 Yet another example of an application for the device is shown in FIGS. 43 and 44 .
  • the device is used for apical closure, e.g. after a transcatheter aortic-valve implantation procedure.
  • An intraventricular patch 22 is applied with the device of FIG. 43 ; and the residual hole in the patch 22 is sealed with a patch 22 (without a center aperture) applied from the opposite side by the device of FIG. 44 .
  • the patches 22 applied by both devices can be linked with a suture 34 or with an extension of the patch material.
  • an intermediate retrieval catheter 58 is used to achieve a uniform profile of deflated distal balloon 21 during retrieval.
  • the distal balloon 21 is pulled into the retrieval catheter 58; and the retrieval catheter is pulled back through the patch 22 while the proximal balloon 40 provides stabilization.
  • the intermediate retrieval catheter 58 includes an expansile distal tip 54 with lower durometer or co-extruded material to accommodate entry of the distal balloon 21 there into.
  • PGSU polyglycerolsebacate urethane
  • the diameter of the patch 22 was 14 mm.
  • the results are shown in FIG. 22 , where the right ventricle (RV) burst pressure is shown via the left-side bar for each defect size, and where the left ventricle (LV) burst pressure is shown via the larger right-side bar in each pair.
  • RV right ventricle
  • LV left ventricle
  • a left-sided patch can withstand burst pressure of over 300 mmHg.
  • the ideal patch/VSD size ratio was found to be about 2.2, as indicated by the bar graph.
  • a polyglycerolsebacate urethane patch 22 was attached to the intact ventricular septum 14 of a pig during beating heart surgery and confirmed by intraoperative trans-epicardial 3-D echocardiography.
  • Results from a pull-off test in which a patch 22 was applied to a septum 14 under various preload forces are plotted in FIG. 23 .
  • ultraviolet light can be delivered via an internal fiber optic 29 to a reflective balloon 21 where it is reflected onto a patch 22 pre-coated with photocurable adhesive 46 to affix the patch 22 to the tissue, prior to removal of the device.
  • the functional components of the device include a reflective distal balloon 21 fixed on an inner shaft 23 and a proximal stabilizing balloon 40 on an intermediate shaft 24 ( FIG. 24 ). All components can be loaded into an outer shaft 25.
  • a UV fiber optic 29 (connected to a UV source 30 at one end and designed for light dispersion at the other) is housed in the inner shaft 23, and can be advanced into the inner lumen until the tip is located in the distal balloon 21.
  • the reflective distal balloon 21 has an outer layer that allows temporary suture-based attachment of a patch/adhesive system ( FIG. 24 ), ensuring the patch 22 unfolds with the distal balloon 21 and can be released from the system in situ.
  • All components can be deflated and loaded into the outer catheter shaft 25 for delivery.
  • the procedural steps are as follows: (i) the catheter is delivered through the defect 20; (ii) the patch 22 is released by pulling back the open suture loop connecting the patch 22 to an outer membrane on the reflective balloon 21; (iii) balloons are deployed (distal balloon 21 first, then proximal balloon 40); (iv) UV light is turned on to activate the photocurable adhesive 46 coated on the proximal side of the patch 22; and (v) both balloons 21 and 40 are fully deflated and removed from the body.
  • the distal reflective balloon 21 is retrieved through a four-leaflet valve in the patch 22, leaving the patch 22 adhered to the tissue.
  • Each shaft 23, 24, and 25 was connected to an ergonomic handle 26, which allowed coupling and uncoupling of each shaft, and enabled volume-controlled inflation and deflation of the balloons 21 and 40 via a syringe 32.
  • Plasma pre-treatment of the urethane balloon substrate which enhances adherence of a metallic coating to the urethane substrate, was performed to improve the reflectivity of both aluminum and palladium.
  • gold and poly(p-xylylene) were coated on aluminum samples and the reflectivity test was repeated. All outer coatings resulted in similar reflectivity.
  • Aluminum particles were deposited on the balloons when a direct current was applied under vacuum (4 mtorr). Urethane balloons were masked on their flat face and taped onto a rotating mount in a sputter chamber.
  • a urethane balloon was pre-treated with plasma, coated with 100 nm of aluminum, and a second outer urethane balloon was applied to act as a barrier between the coating and the external environment and to participate in the patch deployment/release mechanism.
  • the coating thickness varied slightly, but predictably, with distance from the aluminum source, and the adhesion of the coating was improved with poly(p-xylylene) pre-treatment.
  • the internal fiber optic cable 29 delivering the light was sculpted.
  • the tip of the internal fiber optic 29 By shaping the tip of the internal fiber optic 29 and moving it relative to the reflective chamber (varying the insertion distance), reflected light rays are spread over a larger area compared to a flat tip.
  • Light ray trace simulations were used to examine the effect of the fiber tip angle (straight and 20° conical tip) and the fiber depth (0, 10, and 18.5 mm, as measured from the flat face of the distal balloon 21) for a given inflated balloon geometry. The efficiency calculations assumed that 100% of the light is available in the fiber 29 before the light is launched into the catheter.
  • the resulting light irradiance maps demonstrated that a sculpted conical fiber results in more spreading of the light on the adhesive/patch system compared to a flat fiber tip.
  • the favorable spreading of light and light reflectance at each fiber insertion depth was compared.
  • the flat tip had more variability in efficiency, as it is sensitive to fiber position within the inner shaft 23.
  • the conical tip had greater efficiency, and less sensitivity to position in the inner shaft 23.
  • the final design of the fiber optic 29 was a sculpted conical shape, which enabled spreading of light over the entire surface of the 25mm-diameter circular patch 22 by simply moving the fiber 29 along the inner shaft 23 inside the reflective distal balloon 21.
  • the motion of the fiber 29 acts to 'paint' a uniform irradiance on the patch 22.
  • the slightly curved shape of the inflated balloon 21 has a small effect on the efficiencies or ray patterns.
  • the fiber optic tip can be sculpted in a case-specific manner using such simulations.
  • HLAA and a UV light transparent patch 22 made of PGSU were manufactured. Additionally, PGSU patches 22 were laser cut to diameters specified. Eight 0.5-mm holes around the perimeter of the patch 22 and a four-leaflet valve with ⁇ 5 mm slits were laser cut in the center to allow device insertion and withdrawal with minimal residual shunt.
  • the inner shaft 23 (Clear pebax 72D shaft; inner diameter 1.42 mm, outer diameter 1.67mm, length 34 cm, from Vention Medical) was bonded to an aluminum-coated urethane balloon 21 (#20000701 AD from Vention Medical with both necks trimmed to 2 mm) using light curable adhesive 46 (Loctite 3943 from Henkel AG & Co. KGaA) at each neck 50, after skiving the distal end to allow balloon inflation.
  • An identical outer balloon 36 was sutured to the laser cut patch 22 with eight continuous sutures 34 (Prolene 5.0, RB2 from Ethicon US, LLC) around the perimeter of the patch 22, guided by laser cut holes in the patch 22, as shown in FIG. 24 with temporary sutures 34 threaded through the holes.
  • the patch/outer balloon assembly was placed over the coated balloon 21 on the inner shaft 23 and bonded at the distal end with the Loctite 3943 adhesive 46.
  • Adhesion to explanted sections of pig heart, abdominal wall and stomach was tested by activating a hydrophobic light-activated adhesive 46 (HLAA) attached to a poly(glycerol sebacate urethane) (PGSU) patch on the surface of the tissue sample with the catheter balloon device.
  • HLAA hydrophobic light-activated adhesive 46
  • PGSU poly(glycerol sebacate urethane)
  • Successful patch attachment for the heart and abdominal wall was measured by manual pull-off assessment.
  • the balloon 21 was filled to a supraphysiological volume (>1 litre) and demonstrated to be watertight.
  • An abdominal wall reinforcement procedure was performed in a euthanized porcine model carcass to evaluate the spatial interaction between the device and abdominal organs.
  • a small incision was made in the skin of the abdomen and a surgical tunnel was created through the abdominal wall layers for the device insertion. Feasibility of the procedure and patch attachment to the innermost layer of the abdominal wall was successfully demonstrated.
  • the PGSU patch is designed to degrade over time but could be exchanged for a synthetic hernia mesh.
  • the balloon catheter was evaluated as a potential endoscopic tool for tissue closure during natural orifice translumenal endoscopic surgical (NOTES) treatment of lesions of the gastro-intestinal tract.
  • NOTES natural orifice translumenal endoscopic surgical
  • the procedure was performed on an entire porcine stomach, both in a whole deceased animal or with the full stomach on the lab bench. In both cases, the device was inserted through the esophagus and directed toward a defect artificially created on the anterior free wall of the stomach.
  • the patch was firmly attached on the external surface of the stomach. Additional adhesive was applied with a syringe to seal it, and cured directly with the fiber optic (ultimately this could be achieved with application of a second patch).
  • the stomach was filled to capacity (>1 liter) to test patch adhesion to tissue under supraphysiological hyper-distension, and no leaks were observed.
  • a PGSU patch (200 ⁇ m thick and 20mm in diameter) was attached to the tissue by activating a thin layer of pre-coated HLAA with the device (120 seconds activation at 3N pre-load) connected to a UV-light source (OmniCure S2000 from Lumen Dynamics Group Inc.), with a filter in the range of 320 to 390nm.
  • the tissue samples were kept wet with saline before and after patch adhesion. Standard pulloff adhesion testing was performed on an Instron 5566.
  • the adherent PGSU patch was attached to a flat probe using cyanoacrylate glue (Loctite 4601) a compressive preload of -IN was applied for 5 seconds and the patch was pulled off at a rate of 8 mm/min. Maximum force was recorded.
  • cyanoacrylate glue Lictite 4601
  • the procedure was performed in a porcine carcass to evaluate patch attachment to the innermost layer of the abdominal wall (parietal peritoneum). A midline incision of the abdominal wall was performed to visualize the procedure). A 6mm incision was made on the skin of the abdomen and a subcutaneous tunnel was created to facilitate device insertion.
  • an incision of 5 mm was made on the anterior free wall of the stomach.
  • the device was inserted through the esophagus, and patch was attached to the outer wall.
  • the organ was explanted and mounted on a hanging support, and the pylorus was attached, and sealed, to a syringe.
  • the patch was adhered with a catheter. 1ml of HLAA was added to the valve in the patch from the outside with a syringe and cured directly with the fiber optic from the device to seal.
  • the organ was filled to capacity (>1000ml) from the syringe in the pylorus.
  • the VSD was created in a two-step procedure (catheter guidance through the removal, then re-entry into the defect with another device).
  • a reduction of flow diameter through the defect was observed from a VSD diameter of 5.5 mm to 1.4 mm.
  • Reduction in defect to a size of 1.6 mm with open heart surgery is considered adequate, as residual defects less than 2 mm are reported to spontaneously close within 1 year in humans, A. Dodge-Khatami, et al., "Spontaneous closure of small residual ventricular septal defects after surgical repair," 83 Ann. Thorac. Surg. 902-5 (2007 ).
  • FIG. 47 In the proof-of-concept illustrations of FIG. 47 , (A) a schematic of the device is shown in a cross section of the heart; (B) access is shown for an in vivo procedure showing anterolateral thoracotomy, position of echo probe and RV access through a purse-string suture, which is used to maintain a seal around the device during the procedure; (C) an echocardiograph is presented showing visualization of device insertion into the LV (catheter shaft demarcated by dashed lines); (D) an echocardiograph is presented showing the two inflated balloons (demarcated by dashed lines); (E) an echocardiograph is presented with Doppler flow pre-patch implantation showing an average VSD diameter of 5.5mm; (F) an echocardiograph is presented with Doppler flow post-patch implantation showing an average VSD diameter of 1.4mm; (G) an cho of the patch is shown on the septum VSD; (H) the patch is shown adhered on the heart following the procedure.
  • the apparatus and methods can be used for closure of other cardiac defects, such as intracardiac defects; atrial septal defects (ASD); patent foramen ovale (PFO); patent ductus arteriosus (PDA); and defects created by transcatheter procedures, such as trans-apical or trans-septal valve replacements.
  • the patch/adhesive system can be used for closure of the left atrial appendage or for endoventricular cardiac patch plasty [ e.g ., via the Dor procedure, as described in V Dor, et al., "Left ventricular reconstruction by endoventricular circular patch plasty repair: a 17-year experience" (2001 ), for acute left ventricular aneurysm].
  • an atraumatic device that delivers a biodegradable elastic patch and secures it to the ventricular septal wall with a biodegradable adhesive, as described herein, is advantageous for the following reasons: (i) it can provide atraumatic fixation to the septum that does not rely on mechanical anchorage of the occluder; (ii) an elastic patch/adhesive system prevents tissue erosion and electrical conduction damage; (iii) the tunable biodegradability of the system means that no permanent foreign objects remain in the heart; and (iv) attachment to the septal wall on the left ventricular side is favorable in terms of pressure gradients.
  • a maximum waiting time of two minutes was demonstrated for adhesive activation without the need for angiography, using non-invasive echocardiographic guidance instead (and without the use of any mechanical anchorage with only the adhesive providing the anchoring).
  • the apparatus and methods can also be applied to the neck of cranial aneurysms or aortic aneurysms, functioning to effectively seal the aneurysm (or dramatically reduce the neck) from the blood flow in an atraumatic manner, thus preventing rupture.
  • This approach is different from previous approaches in that the patch is cured from inside the defect with reflected light, sealing off the neck.
  • the apparatus and methods can be used for gastrointestinal applications (for example, closing duodenal ulcers, stomach (peptic) ulcers, esophageal ulcers and bowel perforations).
  • the device can enter through the esophagus and exit through the ulcer.
  • Ulcer perforations can have up to a 30 % one-year mortality rate, with intervention-related adverse events being a main contributor to this high rate.
  • Surgical options for large ulcers include pyloroplasty and gastrojejunal/gastroduodenal resection and reconstruction.
  • the role of endoscopic procedures for treatment of perforated peptic ulcer in elective and emergency situations has been controversial, largely due to the absence of a device that seals the ulcer.
  • a NOTES procedure to close ulcers is advantageous, as it does not require general anesthesia, similar to placing a percutaneous endoscopic gastrostomy (PEG) tube; but a reliable gastric closure method has been one of the fundamental challenges.
  • Device described herein, specifically with a double patch configuration may provide a viable solution to this challenge.
  • the apparatus and methods can be used for patching hernias, wherein the device is inserted through the abdominal wall, and the patch is adhered to the abdominal wall.
  • abdominal hernia repair it is well accepted clinically that the weakened area in the muscle wall can be repaired surgically with sutures after the hernia is pushed back into place (herniorrhaphy); however this technique is typically limited to small hernias with healthy surrounding tissues.
  • Hernioplasty is an alternative technique to repair hernias where synthetic mesh patches are attached over the weakened area, but this approach tends to have longer surgical times and can be associated with negative outcomes.
  • laparoscopic hernioplasty involves mesh patch placement from inside the abdominal wall and attaching the mesh with hernia tacks.
  • tack placement is still associated with limitations, such as infection and hernia reoccurrence.
  • the use of a device, as described herein, for hernia repair with a patch and biodegradable adhesive can exploit advantages of laparoscopy without using tacks, thereby avoiding the limitations of tacks.
  • the apparatus and methods can be used for urology applications (for example, as a minimally invasive urethral bulking agent or as an intravesical drug delivery system where a bioerodible sustained release patch is placed in the bladder through the urethra, providing sustained release of drugs to the bladder).
  • urology applications for example, as a minimally invasive urethral bulking agent or as an intravesical drug delivery system where a bioerodible sustained release patch is placed in the bladder through the urethra, providing sustained release of drugs to the bladder).
  • the apparatus and methods can be used as a directional illuminating catheter to aid with endoscopic procedures and to illuminate difficult-to-see areas.
  • the device can be used at the urethrovesical junction (for benign prostatic hyperplasia detection, for example), in the bronchial tree, or in the gastro-intestinal tract for diagnosis of ulcers, constriction, or Crohn's disease.
  • the apparatus and methods can be used for photodynamic therapy with photosensitizers in the UV range.
  • photosensitizers accumulate preferentially in malignant tissues, and photoactivation with appropriate wavelength of light can release toxic molecules that lead to tumor tissue death.
  • the UV wavelengths can be used for this therapy.
  • the photosensitizer porfimer sodium has a peak absorption in the area of 405nm (blue-violet).
  • Photodynamic therapy is approved by the US Food and Drug Administration (FDA) for endobronchial and esophageal cancers, and is being investigated for skin cancers, ovarian cancer, breast cancers and tumors of the retina.
  • FDA US Food and Drug Administration
  • the adhesive can be omitted from the device.
  • the apparatus and methods can use the reflective coating to achieve spatial control and directional enhancement of illuminated areas, minimizing damage of healthy tissues, which can be useful for treatment of cancers, as mentioned above.
  • the balloon can be used to enhance light delivery for applications, such as crosslinking of vascular tissue, treatment of varicosity, or the delivery of a low-power laser for encouraging stem-cell-based regeneration.
  • the methods and apparatus can be adapted to apply a patch for sustained delivery of cells or drug therapy from a shape memory biomaterial or from a material that requires fixation on tissue.
  • the patch can act as a self-sealing access port for multiple entries (for example, in transapical procedures).
  • the light can be focused forward from the catheter ( e.g., to activate glue at the distal end of the catheter directly without the need for the internal reflection).
  • glue e.g., to activate glue at the distal end of the catheter directly without the need for the internal reflection.
  • Examples of this approach include sticking a patch on the epicardium for infarct reinforcement or drug/patch delivery or for attachment of the outer patch in the second stage of apical closure.
  • This approach can also be used to cure glue on the patch after the procedure if the residual hole/cross in the patch is to be sealed. Additionally, this approach can be beneficial for other applications, such as gastrointestinal applications, urethral applications, left atrial appendage closure, photodynamic therapy, etc. (any instance where the glue is to be activated distal to the catheter).
  • the methods and apparatus can (a) use glue or the patch on the liver to stop hemorrhaging, (b) use the patch for left atrial appendage closure, (c) provide abdominal aneurysm closure, (d) provide reinforcement on infarcted tissue; (e) provide apical closure after transcatheter aortic valve implantation (may need double patch) or any other transapical procedure; (f) deliver urethral or vesical bulking agents; (g) provide a vascular or surgical sealant (e.g., via the application of adhesive); (g) deliver a drug/bioagent releasing therapeutic patch, or (h) patch a defect in the spleen.

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ES2841448T3 (es) 2021-07-08
US20170079717A1 (en) 2017-03-23
EP3142586A1 (en) 2017-03-22
DK3142586T3 (da) 2021-01-04
US10588695B2 (en) 2020-03-17
JP2017516536A (ja) 2017-06-22
EP3821818A3 (en) 2021-07-21
US11627949B2 (en) 2023-04-18
EP3142586A4 (en) 2018-04-04
EP3821818A2 (en) 2021-05-19
PL3142586T3 (pl) 2021-05-31

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